Product Detail

Product Description Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15

Recall Number D-241-2013

Classification Class III

Code Info Lot #: 835H, Exp 07/12

Product Distributed Qty 60,210 units

Reason For Recall Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product

Event Detail

Event Id 62625

Product Type Drugs

Status Ongoing

Recalling Firm Fougera Pharmaceuticals Inc., Melville, NY, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2012-07-18

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide